What side effects are associated with this type of intervention?

Common treatments for head and neck cancers, such as radiation therapy and chemoradiation, can lead to a range of side effects. Radiation therapy often causes mucositis, xerostomia (dry mouth), dysphagia (difficulty swallowing), and skin reactions. Chemoradiation, particularly with cisplatin, can add further toxicities including nephrotoxicity (kidney damage), ototoxicity (hearing loss), and increased risk of severe mucositis and hematologic toxicities. The EthosTM System's daily adaptive radiotherapy (DART) aims to minimize these side effects by adjusting the treatment based on daily anatomical changes, potentially reducing the dose to surrounding healthy tissues.

What prior FDA approvals exist?

The FDA has approved several treatments for head and neck cancers, particularly focusing on radiation therapy and chemoradiation. Notably, adjuvant concurrent chemoradiation with cisplatin has been shown to improve locoregional control and overall survival in high-risk patients compared to radiation therapy alone. Additionally, PD-1 inhibitors like nivolumab and pembrolizumab have been approved for patients with recurrent or metastatic head and neck squamous cell carcinoma who have previously been treated with platinum-based chemotherapy. These treatments aim to enhance the efficacy of traditional radiation therapy, similar to the adaptive approach of the EthosTM System.

What other types of research exist?

Promising alternatives to the EthosTM System for head and neck cancer patients include: 1) MRI-guided adaptive radiotherapy, which offers precise imaging and adaptive planning capabilities; 2) Intensity-Modulated Radiotherapy (IMRT) and Volumetric Modulated Arc Therapy (VMAT), which are established techniques with proven efficacy in dose distribution and organ-at-risk sparing; 3) Adaptive multi-modality IMRT, which compensates for anatomic changes and improves dose distribution. These alternatives provide advanced options for personalized and effective treatment.

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Proton Beam Therapy

Adaptive Radiotherapy + Chemotherapy for Head and Neck Cancer (DARTBOARD Trial)

Phase 2

Waitlist Available

Research Sponsored by University of Texas Southwestern Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Pathologically-proven diagnosis of squamous cell carcinoma of the oropharynx, larynx, or hypopharynx. Squamous cell carcinoma of unknown primary is not allowed.

Clinical stage I-IVB (AJCC, 7th edition); stages I-II glottic cancer are excluded

Must not have

Stage I and II glottic carcinoma.

Prior invasive malignancy with an expected disease-free interval of less than 3 years.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new radiation machine called EthosTM that adjusts to the patient's body for treating head and neck cancer. It aims to improve accuracy and reduce side effects by adapting the treatment plan based on regular imaging.

Who is the study for?

Adults diagnosed with squamous cell carcinoma of the oropharynx, larynx, or hypopharynx (excluding some stages and types) who are in good enough health to participate. Pregnant women can't join, nor can those with distant metastasis, prior chemo for this cancer type, severe allergies to similar drugs used here, certain immune conditions including HIV, or overlapping radiation treatment areas.

What is being tested?

This study tests a new radiation system called EthosTM that adapts daily based on patient anatomy changes. It's compared against standard therapy. The trial may include chemotherapy agents like cisplatin or cetuximab depending on the case. Participants will be randomly assigned to receive either adaptive radiotherapy with minimal setup margins or the current standard treatment.

What are the potential side effects?

Radiation therapy side effects often include skin irritation at the treatment site, fatigue, dry mouth/throat issues if treating head and neck cancers; chemotherapy might add nausea/vomiting and increased risk of infections due to lower blood counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with squamous cell carcinoma in my throat, but not from an unknown primary.

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My cancer is between stages I and IVB, but it's not in the early stages of glottic cancer.

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I can take care of myself and am up and about more than half of the day.

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My cancer can be seen or measured on scans, or I've had a small biopsy.

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I am 18 years old or older.

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I have not had my uterus or both ovaries removed.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer is in the early stages and located in my vocal cords.

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I had cancer before, but it's expected to stay away for less than 3 years.

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I have a history of severe immune system problems, including HIV, or have had a transplant.

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I have had radiation in the same area as my current cancer.

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All of my cancer and affected lymph nodes have been surgically removed.

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My cancer has spread to distant parts of my body.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Xerostomia

Secondary study objectives

Development of acute and chronic toxicity in patients treated with and without DART

Patient reported outcomes

Risk of locoregional recurrence with and without DART

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Involved Nodal Radiotherapy with marginless Daily Adaptive Radiotherapy w or w/o chemotherapyExperimental Treatment2 Interventions

Patients in the ML/DART Arm will have their radiation plan adapted with every fraction. The adaptation process will be performed automatically on the Varian Ethos adaptive therapy software under the supervision of the treating physician.

Group II: Involved Nodal Radiotherapy with conventional margins w or w/o chemotherapyActive Control2 Interventions

If a patient loses a significant amount of weight on treatment, or the tumor contour changes substantially, repeat CT simulation and re-planning is allowed in the CM arm. However, the gross tumor volume may not be reduced due to tumor shrinkage. The original extent of disease must be included in the replanned GTV.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Intensity modulated radiation therapy (IMRT) with or without chemotherapy

2022

Completed Phase 2

~50

cisplatin, cetuximab, or carboplatin-paclitaxel

2022

Completed Phase 2

~50

0 / 12Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Head and Neck Cancers include radiation therapy, chemotherapy, and the novel EthosTM System (Daily Adaptive Radiotherapy - DART). Radiation therapy works by damaging the DNA of cancer cells, leading to their death. Chemotherapy uses drugs to kill rapidly dividing cells, including cancer cells, by interfering with their DNA replication or other critical cellular functions. The EthosTM System enhances traditional radiation therapy by allowing daily adjustments based on the patient's current anatomy, improving precision and reducing damage to surrounding healthy tissues. This is particularly important for Head and Neck Cancer patients as it can increase treatment effectiveness while minimizing side effects, leading to better overall outcomes.